| November 12, 2016 |
summary |
Objective: The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on metabolic profiles in gestational diabetes. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion criteria: pregnant women aged 18-40 years old diagnosed with GDM at 24-28 weeks\' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles. Start and End Date of Intervention: 6 weeks (July 1, 2015-August 12, 2015). Outcomes: Fasting plasma glucose (FPG), serum insulin levels and lipid profiles will be measured at study baseline and end-of-trial.
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